Delving into the Latest Updates on Olendalizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Lendalizumab (USAN), Olendalizumab (USAN), lendalizumab

+ [1]

Target

C5a

Action

inhibitors

Mechanism

C5a inhibitors(complement C5a inhibitors)

Therapeutic Areas

Immune System Diseases

Active Indication

Graft Rejection

Inactive Indication

Acute Graft Versus Host DiseaseAntiphospholipid SyndromeGraft versus host disease in gastrointestinal tract+ [1]

Originator Organization

Alexion Pharmaceuticals, Inc.

Active Organization

Alexion Pharmaceuticals, Inc.

Inactive Organization

Immune Disease Institute, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 3876H

Source: *****

Sequence Code 3818L

Source: *****

Involvement of lower gastrointestinal tract (LGI) occurs in 60% of patients with graft-versus-host-disease (GVHD). Complement components C3 and C5 are involved in GVHD pathogenesis. In this phase 2a study, we evaluated the safety and efficacy of ALXN1007, a monoclonal antibody against C5a, in patients with newly diagnosed LGI acute GVHD receiving concomitant corticosteroid. Twenty-five patients were enrolled; one was excluded from the efficacy analysis based upon negative biopsy. Most patients (16/25, 64%) had acute leukemia; 52% (13/25) had an HLA-matched unrelated donor; and 68% (17/25) received myeloablative conditioning. Half the patients (12/24) had a high biomarker profile, Ann Arbor score 3; 42% (10/24) had high-risk GVHD per Minnesota classification. Day-28 overall response was 58% (13/24 complete response, 1/24 partial response), and 63% by Day-56 (all complete responses). Day-28 overall response was 50% (5/10) in Minnesota high-risk and 42% (5/12) in high-risk Ann Arbor patients, increasing to 58% (7/12) by Day-56. Non-relapse mortality at 6-months was 24% (95% CI 11-53). The most common treatment-related adverse event was infection (6/25, 24%). Neither baseline complement levels (except for C5), activity, nor inhibition of C5a with ALXN1007 correlated with GVHD severity or responses. Further studies are needed to evaluate the role of complement inhibition in GVHD treatment.

100 Deals associated with Olendalizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11331	-	-	DB14834

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Graft Rejection	Phase 2	-	Alexion Pharmaceuticals, Inc.	-
Acute Graft Versus Host Disease	Phase 1	United States	Alexion Pharmaceuticals, Inc.	14 Nov 2014
Acute Graft Versus Host Disease	Phase 1	France	Alexion Pharmaceuticals, Inc.	14 Nov 2014
Antiphospholipid Syndrome	Phase 1	United Kingdom	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	United States	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	Japan	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	Spain	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	Brazil	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	France	Immune Disease Institute, Inc.	-
Antiphospholipid Syndrome	Phase 1	Italy	Immune Disease Institute, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02245412 (GIGVHD, CTgov)	Phase 2	Acute Graft Versus Host Disease \| Graft versus host disease in gastrointestinal tract	25	ALXN1007 10 mg/kg once weekly (ALXN1007 10 mg/kg Once Weekly)	kzxaurvezv(jxdvrfivou) = lmjppcdrvs mehcgnjhdb (qnhgvsadcq, oqnlwhdlwe - ejlhhjjlgr) View more	-	06 Oct 2017
NCT02245412 (GIGVHD, CTgov)	Phase 2		25	ALXN1007 20 mg/kg once weekly (ALXN1007 20 mg/kg Once Weekly)	kzxaurvezv(jxdvrfivou) = wzrrahbymi mehcgnjhdb (qnhgvsadcq, zyeotrdnaj - oxcstjabli) View more	-	06 Oct 2017
NCT02128269 (CTgov)	Phase 2	Antiphospholipid Syndrome	9	Study Drug- ALXN1007	zisopuqbix(eucplcblse) = ezukvlypof mcjrwnzszz (bznwlwxufn, trjmrarddj - zgqyzwvori) View more	-	13 Jul 2017

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Olendalizumab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation